Device recall
Z-2971-2020: Cook Medical Universa Soft Ureteral Stent Sets-5 FR 26 cm Reference part Number…
FDA device recall · Class II · Cook Inc.
Key facts
| Recall number (Z-number) | Z-2971-2020 |
|---|---|
| Recall event | 86256 |
| Product | Cook Medical Universa Soft Ureteral Stent Sets-5 FR 26 cm Reference part Number: UFH-526 - Product Usage: Used for temporary internal drainage from the ureteropelvic junction to the bladder |
| Product code | FAD |
| Recalling firm | Cook Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 4, 2021 |
| 510(k) numbers | K151051, K161236 |
| FEI number | 1820334 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database